Sprecher

Jean-Francois Decoster, UCB Pharma, Belgium

Sandra Hafner, AbbVie Deutschland, Germany

Dr Gerald Kindermann, F. Hoffmann-La Roche, Switzerland

Torsten Kneuss, Bayer, Germany

Horst Koller, HK Packaging Consulting, Switzerland

Dr Jörg Zürcher, Bayer, Germany

Zielsetzung

The focus of these 2 GMP Education Courses is on the development and routine control of pharmaceutical packaging systems.

In Course 1 participants will learn how to develop pharmaceutical packaging materials systematically, and how to translate the requirements of the Common Technical Document (CTD) to regulatory documents for packaging materials. Topics to be addressed include compendial standards, container closure integrity, and combination products.

Course 2 will focus on the testing of a variety of different packaging materials, as carried out in every incoming-goods laboratory in quality control. This includes the setting of sound and scientific specifications and Acceptable Quality Levels (AQLs), the control of dimensions, and the control of primary and secondary packaging materials.

Hintergrund

There is a great number of regulatory requirements on pharmaceutical packaging materials, in the pharmacopoeias, the GMP regulations, in the FDA guidances, etc.
Packaging materials also have to be described in the registration process of a drug product according to the requirements of the CTD.

The development of pharmaceutical packaging systems is an increasingly complex topic, which is reflected in the most recent requirements for combination products. To cover all relevant aspects a thorough target product profile needs to be set up. Not only regulatory requirements drive container closure system development, also current hot topics such as container closure integrity and glass delamination need to be considered as well.

Furthermore, the pharmaceutical manufacturer has to guarantee that only such packaging materials are used that are correctly printed on, in conformity with the specifications and in compliance with the regulatory requirements.

In order to determine the scope of the tests for the quality control of pharmaceutical packaging materials, the “Defect Evaluation Lists” have proved efficient. The responsibility for the tests lies now more and more with the manufacturers of packaging materials, while the pharmaceutical industry tries to reduce testing at the same time. However, as a precondition for this, additional QA measures, like supplier qualification, audits and supply agreements, have to be taken.

Zielgruppe

These GMP Education Courses are designed for employees working in pharmaceutical research and development, regulatory affairs, quality control, incoming goods control of packaging materials, and quality assurance departments. They are also directed at employees of suppliers of primary and secondary packaging materials for the pharmaceutical industry.

Special Defect Evaluation Lists: Containers made of moulded and tubular glass

Control of Printed Packaging Materials

Legal requirements

Level of certification

Sample size & test procedures

Reference samples vs. retention samples (Annex 19)

Calibration/Qualification/Validation

Definitions

Regulatory requirements

Equipment lifecycle qualification for the control of packaging materials

Process validation

Quality Control of Primary Packaging Material

What is a suitable QC system for Primary Packaging Materials

Definition of critical parameters

Best practice in testing

AQL-testing, skip lot

Must to have QA systems (i.e. OOS, complaints)

Sample management incl. reference samples

Supplier Management

Supplier qualification and audits

Supply agreements and supplier qualification

Quality standards for suppliers

Cascade of Quality Control, reduced testing

Sampling plans

Dimensional Checks in Packaging Development and Quality Control

Measurement equipment: overview

Application ranges

Practical examples

Technical Specifications

Scope & content

Concept (proposal)

Template and practical example

WORKSHOP I
Examples of Defective Glass Packaging Materials (60 min)
The aim of this workshop is to discuss in small discussion groups the evaluation of some defective packaging materials that are presented. Are the defects of these packaging materials critical or non-critical? Has the lot to be rejected or can it still be used?
Participants will learn how to apply the general recommendations of accepted and published Defect Evaluation Lists for specific and individual packaging materials.

WORKSHOP II
Risk Management (Focus: FMEA)
The aim of this workshop is to define in small discussion groups the critical/major parameters to build up a suitable quality control system for your packaging materials. Focus will be on the practical application in a FMEA. The groups will evaluate